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Prevention of Early Postoperative Decline (PEaPoD)

Beth Israel Lahey Health logo

Beth Israel Lahey Health

Status

Completed

Conditions

Delirium
Postoperative Cognitive Dysfunction

Treatments

Device: Lumosity

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02908464
2016P000145

Details and patient eligibility

About

The purpose of this trial is to determine whether using a brain training program in the time leading up to as well as after heart surgery will reduce confusion and cognitive loss that can occur after surgery.

Full description

Randomized, controlled pilot study with a convenience sample of 45 adult cardiac surgical patients. The main intervention to be studied will be the use of a neurocognitive training program (Lumosity) for 10 days preoperatively, and then for four weeks postoperatively. The prescribed regimen of training will focus on the areas of cognitive function most commonly affected in the postoperative period, including working memory, attention, and processing speed. Patients in the control arm will undergo current standard cardiac surgical postoperative care and will be asked to refrain from obtaining a Lumosity account.

Enrollment

45 patients

Sex

All

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients undergoing cardiac surgery age 60-90
  • Cardiac surgery scheduled at least 10 days from enrollment
  • High school education level or equivalent

Exclusion criteria

  • Preexisting psychiatric illness
  • History of cerebrovascular event or seizure
  • Non English speakers
  • Baseline severe cognitive dysfunction including Alzheimer's, Parkinson's, or other severe forms of dementia
  • Significant visual impairment
  • Enrollment in another study involving cognition

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 2 patient groups

Lumosity (CT Group)
Experimental group
Description:
Patients in the Lumosity arm will be prescribed a perioperative neurocognitive training program created in collaboration with Lumos Labs, Inc. The program will contain "brain games" that focus on enhancing cognitive abilities in working memory, attention, and processing speed. Participants will be expected to complete at least 2, but no more than 3, 15 minute sessions of training per day. The protocol will be prescribed for 10 days preoperatively, and then for four weeks postoperatively.
Treatment:
Device: Lumosity
Usual Care (Control Group)
No Intervention group
Description:
Patients in the usual care arm will undergo current standard of care for cardiac surgery and postoperative recovery. They will be asked to refrain from acquiring a Lumosity account.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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